Trial to Assess the Influence of 4 Weeks' Treatment With Linagliptin as Compared to Glimepiride and Placebo on Endothelial Function in Patients With Type 2 Diabetes Using FMD (Flow-Mediated Vasodilation)

Change From Baseline in Flow Mediated Vasodilation (FMD) Under Fasted Condition on Day 28 [ Time Frame: baseline and day 28 for each treatment arm ] [ Designated as safety issue: No ]

Endothelial function under fasted condition was measured with flow mediated vasodilation (FMD). The change from baseline was calculated as the value on Day 28 divided by the respective value at baseline.

Original Primary Outcome Measures ICMJE (submitted: October 9, 2012)

Change from baseline in endothelial function as measured with flow mediated vasodilation (FMD) at baseline (fasting), and on day 28 (fasting) [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]

Change From Baseline in Flow Mediated Vasodilation (FMD) 2 h Post Meal on Day 28 [ Time Frame: baseline and day 28 for each treatment arm ] [ Designated as safety issue: No ]

Endothelial function 2 hours post meal was measured with flow mediated vasodilation (FMD). The change from baseline was calculated as the value on Day 28 divided by the respective value at baseline.

Change From Baseline in 2 Hours Post Meal Endothelial Independent Vasodilation (EIDV) on Day 28 [ Time Frame: baseline and day 28 for each treatment arm ] [ Designated as safety issue: No ]

Endothelial function 2h post-meal was measured by endothelial independent vasodilation (EIDV). The change from baseline was calculated as the value on Day 28 divided by the respective value at baseline.

Number of Patients With Adverse Events [ Time Frame: up to 20 weeks ] [ Designated as safety issue: No ]

Change from baseline in endothelial independent vasodilation (EIDV) at baseline (fasting), and on day 28 (fasting) [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]

Number of patients with adverse events [ Time Frame: up to 25 weeks ] [ Designated as safety issue: No ]

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

Trial to Assess the Influence of 4 Weeks' Treatment With Linagliptin as Compared to Glimepiride and Placebo on Endothelial Function in Patients With Type 2 Diabetes Using FMD (Flow-Mediated Vasodilation)

Official Title ICMJE

Randomized, Three Period Cross Over, Double Blind, Double Dummy Study in Type 2 Diabetic Patients to Assess the Endothelial Effects of Linagliptin, Glimepiride and Placebo Therapy for 28 Days ('ENDOTHELINA')

Brief Summary

The general aim of the present study is to investigate the impact of 4 weeks treatment with linagliptin (5 mg) on endothelial function in patients with type 2 diabetes mellitus. In the current trial this effect of linagliptin treatment on endothelial function will be compared against both the sulfonylurea glimepiride and against placebo, which has not been tested in a trial before; as also is the case for other DPP-4 inhibitors.

Besides placebo, glimepiride was chosen as a comparator, as it is one compound of the second most used oral antidiabetic drug class.